Certain polyoxypropylene/polyoxyethylene copolymers have been found to have beneficial biological effects when administered to a human or animal. A group of polyoxypropylene/polyoxyethylene copolymers have been found to inhibit the growth of microorgansims, such as bacteria, yeasts and viruses. For example, these surface-active copolymers have been shown to inhibit human immunodeficiency virus (HIV), Mycobacteria species and Toxoplasma gondii.
The antiinfective activity of the surface active copolymers and the use of the surface active copolymers as therapeutic delivery agents are described in detail in copending U.S. patent applications Ser. Nos. 08/161,551 and 08/138,271 both of which are incorporated herein by reference.
The surface-active copolymers are effective in treating a viral infection in a human or animal including infections caused by the HIV or related viruses. The present invention provides a composition that can be administered to patients who are infected with HIV or similar viruses. The surface-active copolymer is effective in inhibiting or suppressing the replication of the HIV and related virus strains in cells.
The surface-active copolymers are useful for treating infections caused by microorganisms when used alone or with a conventional antibiotic. Several conventional antibiotics that can be used with the surface-active copolymer include, but are not limited to, rifampin, isoniazid, ethambutol, gentamicin, clindamycin, pyrimethamine, tetracycline, and erythromycin.
The surface active copolymers can be used to deliver therapeutic drugs to a human or animal for treating disease states such as, but not limited to, bacterial infection and infections caused by HIV and other DNA and RNA viruses. The methods relate particularly to compositions and methods for treating infectious diseases and genetic disorders through gene therapy and intracellular delivery of antisense oligonucleotides or other nucleic acid sequences.
The surface active copolymers are effective for treating a disease state comprising an administerable admixture of an effective amount of a therapeutic compound capable of altering nucleic acid sequence function and an effective amount of the surface active nonionic block copolymer.
The surface active copolymers can be used in an admixture of a compound capable of altering gene expression and/or protein translation, such as an antisense oligonucleotide, a triplex DNA compound, a ribozyme or other compound capable of altering nucleic acid sequence function, and the surface active copolymer.
Because the commercially available sources of the polyoxypropylene/polyoxyethylene copolymers have been reported to contain components that exhibit toxicity as well as variation in biological activity, what is needed is a preparation of polyoxypropylene/polyoxyethylene copolymers which retain the therapeutic activities of the commercial preparations but are free from their other biological activities such as toxicity. It is well known in the art that the unsaturation is produced during the polymerization of the polypropylene hydrophobe and unsaturation results in reduced functonality and reduced stability. The reduced functionality results in the formation of impurities with diblock type structure upon subsequent polymerization of the hydrophobe with ethylene oxide. Therefore what is needed is a composition with less unsaturation and less diblock type impurities. In addition, what is needed is a preparation of polyoxypropylene/polyoxyethylene copolymers which is less polydisperse in molecular weight, more stable, is less cardiotoxic, and is more efficacious.